Intraosseous sliding osteotomy system and method

ABSTRACT

A system includes an intraosseous sliding osteotomy (ISO) plate including a body extending between a first end, a second end, a first surface, a second surface, and a perimeter wall. The body defines at least one fastener aperture extending from the first surface to the second surface. A plate handle is configured to be coupled to the ISO plate. The plate handle includes a body including a handle portion and a head portion. The head portion defines at least one aperture. A locking element includes a locking portion sized and configured to extend through the at least one aperture defined in the head portion of the plate handle to couple the plate handle to the ISO plate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Provisional Application Ser. No.62/774,373, filed on Dec. 3, 2018, entitled “INTRAOSSEOUS SLIDINGOSTEOTOMY SYSTEM AND METHOD,” which is incorporated by reference hereinin its entirety.

BACKGROUND

The forefoot includes five toes (which are also known as “phalanges”)and connecting long bones (or “metatarsals”). Several small bonestogether comprise a phalanx or toe. The phalanges are connected to themetatarsals at the ball of the foot. The forefoot balances pressure onthe ball of the foot and bears a substantial amount of the body weight.The forefoot is often the subject of trauma, such as results from falls,vehicle, crashes and dropped objects. These accidents often result insevere fractures and/or dislocations. In addition, there are severalconditions which result from congenital deformation or which arise as aresult of repeated use type injuries. Surgical intervention thatincludes surgical sectioning of bone or an “osteotomy” is often used torestructure the bones as a treatment for such conditions.

SUMMARY

In various embodiments, a system is disclosed. The system includes anintraosseous sliding osteotomy (ISO) plate including a body extendingbetween a first end, a second end, a first surface, a second surface,and a perimeter wall. The body defines at least one fastener apertureextending from the first surface to the second surface. A plate handleis configured to be coupled to the ISO plate. The plate handle includesa body including a handle portion and a head portion. The head portiondefines at least one aperture. A locking element includes a lockingportion sized and configured to extend through the at least one aperturedefined in the head portion of the plate handle to couple the platehandle to the ISO plate.

In various embodiments, a kit is disclosed. The kit includes anintraosseous sliding osteotomy (ISO) plate having a body extendingbetween a first end, a second end, a first surface, a second surface,and a perimeter wall. The body defines at least one fastener apertureextending from the first surface to the second surface. The kit furtherincludes a plate handle, a locking element configured to couple the ISOplate to the plate handle, a non-locking drill guide comprising a bodyand an insert receiving portion coupled to the body, and a broachcomprising a broach handle and a broach insert.

In various embodiments, a method of forming an osteotomy is disclosed.The method includes a step of inserting a portion of a broach into a cutformed in a bone. The broach is rotated to displace a first portion ofthe bone from a second portion of the bone. An intraosseous slidingosteotomy (ISO) plate is inserted into the second portion of the bone.The ISO plate is coupled to a plate handle by a locking drill guide andthe plate handle applies a force to the ISO plate. A first channel isformed in the first portion of the bone using a non-locking drill guideinserted at least partially into a first aperture defined in the ISOplate and a first fastener is inserted through the first aperturedefined in the ISO plate into the first channel in the first portion ofthe bone to couple the ISO plate to the first portion of the bone.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present invention will be more fullydisclosed in, or rendered obvious by the following detailed descriptionof the preferred embodiments, which are to be considered together withthe accompanying drawings wherein like numbers refer to like parts andfurther wherein:

FIG. 1A illustrates an intraosseous sliding osteotomy (ISO) plate, inaccordance with some embodiments.

FIG. 1B illustrates a side view of the ISO plate of FIG. 1A, inaccordance with some embodiments.

FIG. 1C illustrates a cross-section of the ISO plate of FIG. 1A takenalong line A-A, in accordance with some embodiments.

FIG. 2A illustrates a plate handle configured to be coupled to an ISOplate, in accordance with some embodiments.

FIG. 2B illustrates a cross-section of the plate handle of FIG. 2A takenalong line A-A, in accordance with some embodiments.

FIG. 3A illustrates a locking drill guide configured to be coupled to aplate handle, in accordance with some embodiments.

FIG. 3B illustrates a cross-section of the locking drill guide of FIG.3A taken along line A-A, in accordance with some embodiments.

FIG. 4A illustrates a driver configured to be coupled to one or moreelements of an ISO plate system, in accordance with some embodiments.

FIG. 4B illustrates a cross-section of the driver of FIG. 4A taken alongline A-A, in accordance with some embodiments.

FIG. 5A illustrates a drill guide configured to be coupled to an ISOplate, in accordance with some embodiments.

FIG. 5B illustrates a top view of the drill guide of FIG. 5A, inaccordance with some embodiments.

FIG. 5C illustrates a front view of the drill guide of FIG. 5A, inaccordance with some embodiments.

FIG. 5D illustrates a drill guide insert configured to be coupled to thedrill guide of FIG. 5A, in accordance with some embodiments.

FIG. 5E illustrates a cross-section of an insert guide portion and andrill guide insert along line A-A of FIG. 5C, in accordance with someembodiments.

FIG. 6A illustrates a broach including a handle and an insert, inaccordance with some embodiments.

FIG. 6B illustrates a cross-section of the broach of FIG. 6A, inaccordance with some embodiments.

FIG. 6C illustrates the handle of the broach of FIG. 6A, in accordancewith some embodiments.

FIG. 6D illustrates the insert of the broach of FIG. 6A, in accordancewith some embodiments.

FIG. 7 illustrates a method of forming an osteotomy in a bone, inaccordance with some embodiments.

FIG. 8A illustrates a step of forming an osteotomy in a bone, inaccordance with some embodiments.

FIG. 8B illustrates a step of offsetting a first bone portion from asecond bone portion using a broach, in accordance with some embodiments.

FIG. 8C illustrates a step of inserting an ISO plate into a second boneportion, in accordance with some embodiments.

FIG. 8D illustrates a step of forming a first screw hole in a first boneportion, in accordance with some embodiments.

FIG. 8E illustrates a step of coupling the ISO plate to the first boneportion using a first screw, in accordance with some embodiments.

FIG. 8F illustrates a step of forming a second screw hole in a firstbone portion, in accordance with some embodiments.

FIG. 8G illustrates a step of coupling the ISO plate to the second boneportion using a second screw, in accordance with some embodiments.

FIG. 8H illustrates a step of forming a screw hole in a second boneportion, in accordance with some embodiments.

FIG. 8I illustrates a step of inserting a compression screw into asecond bone portion, in accordance with some embodiments.

FIG. 9A illustrates a front view of a plate handle coupled to an ISOplate using a first a locking drill guide and a second locking drillguide, in accordance with some embodiments.

FIG. 9B illustrates a front perspective view of the plate handle of FIG.9A, in accordance with some embodiments.

FIG. 9C illustrates a side view of the plate handle of FIG. 9A, inaccordance with some embodiments.

FIG. 10 illustrates a top perspective view of a locking drill guide, inaccordance with some embodiments.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. In the description, relativeterms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,”“below,” “up,” “down,” “top,” “bottom,” “proximal,” “distal,”“superior,” “inferior,” “medial,” and “lateral” as well as derivativethereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing under discussion. These relative terms are for convenienceof description and do not require that the apparatus be constructed oroperated in a particular orientation. Terms concerning attachments,coupling and the like, such as “connected,” refer to a relationshipwherein structures are secured or attached to one another eitherdirectly or indirectly through intervening structures, as well as bothmovable or rigid attachments or relationships, unless expresslydescribed otherwise. Like elements have been given like numericaldesignations to facilitate an understanding of the present subjectmatter.

As used herein, the term “substantially” denotes elements having arecited relationship (e.g., parallel, perpendicular, aligned, etc.)within acceptable manufacturing tolerances. For example, as used herein,the term “substantially parallel” is used to denote elements that areparallel or that vary from a parallel arrangement within an acceptablemargin of error, such as +/−5°, although it will be recognized thatgreater and/or lesser deviations can exist based on manufacturingprocesses and/or other manufacturing requirements.

In various embodiments, systems and methods of forming an osteotomy in afirst bone are disclosed. The system includes an intraosseous slidingosteotomy (ISO) plate. The ISO plate is configured to be inserted into amedullary canal of a first bone portion. The ISO plate includes one ormore locking screw holes each configured to receive a locking screwtherein and a compression screw hole configured to receive a compressionscrew therein. The system further includes a broach, a locking drillguide, a non-locking drill guide, a driver handle, driver insert, and aplurality of screws. In some embodiments, one or more elements of thesystem include an injected molded material.

In various embodiments, a method for inserting an ISO plate isdisclosed. The method includes.

FIGS. 1A-1C illustrate an ISO plate 2, in accordance with someembodiments.

The ISO plate 2 includes a body 4 extending between a first surface 6and a second surface 8 and defined by a perimeter wall 10. In theillustrated embodiment, the first surface 6 and the second surface 8define substantially parallel planes defining a substantially constantthickness, although it will be appreciated that the first surface 6 andthe second surface 8 can be angled such that a thickness of the plateincreases and/or decreases from a first end 12 to a second end 16.

In some embodiments, the plate 2 includes a plurality of portionsdefined by the perimeter wall 10. For example, as shown in FIG. 1A, theplate 2 can include a first (or insertion) portion 18 extending from afirst end 12 of the plate 2 to a first mid-point 24 a of the plate 2, asecond (or compression) portion 20 extending from the first mid-point 24a to a second mid-point 24 b, and a third (or fixation) portion 22extending from the second mid-point to the second end 16 of the plate 2.Although mid-points 24 a, 24 b are provided for illustration purposes,it will be appreciated that the ISO plate 2 is continuous and that themid-points 24 a, 24 b can be located at any suitable location on theplate 2 to denote continuous and/or separate portions 18-22. In someembodiments, one or more of the plate portions 18-22 can be omittedand/or combined.

In some embodiments, the insertion portion 18 defines a portion of theplate 2 sized and configured for insertion into a medullary canal of thebone. The insertion portion 18 defines a tapered portion having athickness extending between the perimeter wall 10 that increases fromthe first end 12 to the first mid-point 24 a. The perimeter wall 10 candefine any suitable taper angle from the first end 12 to the firstmid-point 24 a. For example, in various embodiments, the perimeter wall10 can include a first portion 10 a and a second portion 10 b definingthe tapered insertion portion 18. The first portion 10 a and/or thesecond portion 10 b can define a taper angle with respect to alongitudinal axis 15, such as, for example, 5-15° (e.g., 5°, 7°, 8°, 9°,10°, 11°, 13°, 15°, etc.), 5-25°, 5-75°, and/or any suitable angle. Insome embodiments, the first portion 10 a and the second portion 10 b areparallel (define a 0° angle) and the insertion portion 18 defines aconstant thickness.

In some embodiments, the insertion portion 18 includes a leading edge14. The leading edge 14 can include a sloped or tapered edge configuredto assist insertion of the plate 2 into the medullary canal, forexample, by providing a smaller initial insertion area. The leading edge14 can define a tapered portion extending from the first end 12 of theplate 2 and defining an increasing thickness. The thickness of theleading edge increases from a first thickness at the first end 12 to asecond thickness equal to the thickness of the second portion 20 of theplate 2. In some embodiments, the leading edge 14 is sharpened to definea cutting edge. The leading edge 14 can define any suitable taper anglebetween the first surface 6 and the second surface 8, such as, forexample, 5-15° (e.g., 5°, 7°, 8°, 9°, 10°, 11°, 13°, 15°, etc.), 5-25°,and/or any suitable angle. In some embodiments, the leading edge 14 isomitted and the insertion portion 18 defines a constant thickness equalto a plate thickness of the plate 2 at the second portion 20. Theinsertion portion 18 is configured to be inserted into a medullary canalof a first portion of a bone having an osteotomy formed therein, such asa first portion of a metatarsal.

In some embodiments, the compression portion 20 defines a non-lockingfastener aperture 30 extending through the plate 2 from the firstsurface 6 to the second surface 8 at a predetermined angle. Thepredetermined angle can include any suitable angle with respect to thefirst surface 6 and/or the second surface 8. For example, in variousembodiments, the non-locking fastener hole 30 can extend through theplate 2 at an angle between 35-45° (e.g., 35°, 37°, 39°, 40°, 41°, 43°,45°, etc.), 30-50°, 5-90°, and/or any suitable angle. In someembodiments, the non-locking fastener aperture 30 is configured todirect a fastener inserted therethrough into the first portion of a bonehaving an osteotomy formed therein, such as the first portion of themetatarsal that previously received the insertion portion 18 therein.

In some embodiments, a shroud 32 extends from the second surface 8 ofthe plate 2. The shroud 32 defines a portion of the non-locking fastenerhole 30 extending through the plate 2. The shroud 32 is configured toreceive a head of a non-locking screw such that when a non-locking screwis inserted through the non-locking fastener hole 30, the non-lockingscrew head is contained entirely within the shroud 32. The shroud 32 canextend any suitable distance from the second surface 8 of the plate 2sufficient to allow the head of the non-locking screw to be positionedentirely within the shroud 32.

In some embodiments, the plate 2 includes a plurality of lockingfastener apertures 40 a, 40 b extending from the first surface 6 to thesecond surface 8 of the plate 2. The locking fastener apertures 40 a, 40b can include apertures configured to receive a locking fastener (e.g.,an “Ortholoc® 3Di™” locking screw sold by Wright Medical Technology,Inc. of Memphis, Tenn.), inserted therethrough. The fastener may bedisposed transversely or obliquely, relative to the fastener aperture 40a, 40 b. In some embodiments, polyaxial screws can be inserted with anangle of 0.0 to about 15 degrees from the transverse axis of the lockingfastener aperture 40. In some embodiments, polyaxial screws such asOrtholoc 3Di™ locking screws or non-locking screws sold by WrightMedical Technology, Inc. of Memphis, Tenn. may be utilized. In someembodiments, the locking fastener apertures 40 a, 40 b are configured todirect a fastener inserted therethrough into a second portion of a bonehaving an osteotomy formed therein, such as a second portion of ametatarsal. U.S. Pat. No. 9,005,255 is incorporated herein by referencein its entirety.

FIGS. 2A-2B illustrate a plate handle 100 configured to be coupled tothe ISO plate 2 of FIGS. 1A-1C, in accordance with some embodiments. Theplate handle includes a body 102 extending from a first (or proximal)end 104 to a second (or distal) end 106. The body 102 is defined by anupper surface 108 a, a lower surface 108 b, and a perimeter 110. In someembodiments, the body 102 generally extends along a longitudinal axis112 extending from the first end 104 to the second end 106. Theperimeter 110 defines a profile sized and configured to be gripped by auser, such as a surgeon. For example, in various embodiments, theperimeter 110 defines a plurality of peaks 112 a-112 c and valleys 114a-114 b on each side configured to facilitate gripping and/ormanipulation by a user.

In some embodiments, the plate handle 100 includes a handle head 116positioned at a distal end 106 of the body 102. The handle head 116 iscoupled to the body 102 by a neck 118. The neck 118 defines a thicknessless than the average thickness of the plate body 102. The handle head116 defines an opening sized and configured to receive at least onelocking drill guide (described in greater detail with respect to FIGS.3A-3B) therein. For example, in the illustrated embodiment, the handlehead 116 defines a generally reverse C-shaped body having an opening 120defined by a first circular portion 122 a, a second circular portion 122b, and a channel 123 extending from the circular portions 122 a, 122 bto a distal edge of the reverse C-shaped body. Although specificembodiments are illustrated, it will be appreciated that the handle head116 can define any suitable shape having at least one opening configuredto receive at least one locking drill guide therethrough, such as, forexample, a generally “O” or “0” shaped opening, a generally “8” or “B”shaped opening, etc. The circular portions 122 a, 122 b can becontinuous (as shown in the illustrated embodiment) or discontinuous(for example, in a “B” shaped embodiment) and can define an openingextending to an outer edge of the handle head 116 (for example, in a “C”shaped embodiment as illustrated) or can be closed (for example, in a“O” or “B” shaped embodiment.)

In some embodiments, the handle body 102 defines a tapered portion 126adjacent a proximal end 104 of the body 102. The tapered portion 126includes a portion of the body 102 having a thickness that increasesfrom a first thickness to a second, greater thickness towards theproximal end 104 of the body 102. In some embodiments, the firstthickness is the thickness of the remainder of the handle body 102. Thetapered portion 126 functions as a stop or movement-limiting portion tomaintain a user's hand position on the handle 100 during use. In someembodiments, a proximal edge 124 of the body 102 defines an impact orstriking surface configured to receive an impact during insertion of aplate 2 coupled to the handle 100.

In some embodiments, the plate handle 100 (or a portion thereof) can beformed by injection molding material such as polycarbonate (PC),polyacrylamide (such as Ixef® PARA available from Solvay Group,Belgium), and/or any other suitable injection molding material. Theinjection molding can be formed over one or more structural features,such as ribs, lattice, etc. to provide increased strength and/or towithstand insertion forces applied to the plate handle 100 duringinsertion of an ISO plate 2. In some embodiments, the plate handle 100(or a portion thereof) is formed of a metal material and can be formedusing any suitable process, such as by stamping, bending, cutting,milling, etc.

FIGS. 3A-3B illustrate a locking drill guide 200 configured to couplethe plate 2 to the plate handle 100, in accordance with someembodiments. The locking drill guide 200 includes a body 202 extendingfrom a first end 204 to a second end 206. In the illustrated embodiment,the body 202 includes a generally cylindrical body extending the firstend 204 to the second end 206, although it will be appreciated that thebody 202 can include any suitable shape, such as a regular and/orirregular geometric shape. The body 202 defines a channel 208 (shown inFIG. 3B) extending therethrough from the first end 204 to the second end206. In the illustrated embodiment, the channel 208 extends parallel toa longitudinal axis 210 of the body 202, although it will be appreciatedthat the channel 208 can extend through the body 202 at any suitableangle with respect to the longitudinal axis 210 of the body.

A locking extension 212 extends from a first end 204 of the body 202.The locking extension 212 is formed integrally with the body 202 anddefines a portion of the channel 208 therethrough. The locking extension212 includes at least one locking feature 214 configured to couple thelocking drill guide 200 to an ISO plate, such as the ISO plate 2discussed in conjunction with FIGS. 1A-1C. In the illustratedembodiment, the locking feature 214 includes a thread 216 sized andconfigured to couple to a thread included in at least one lockingaperture defined in the ISO plate 2, although it will be appreciatedthat other suitable locking features, such as pins, fins, press-fitfeatures, etc. can be used to couple the locking drill guide 200 to theISO plate 2.

The first end 204 of the body 202 defines a handle contact edge 218sized and configured to contact a portion of a head 116 of plate handle100. For example, in the illustrated embodiments, the head 116 defines afirst circular opening 122 a and a second circular opening 122 b eachsized and configured to receive the locking extension 212 therethrough.When the locking extension 212 is inserted through one of the first orsecond circular openings 122 a, 122 b, the contact edge 218 contacts asurface of the head 116. When the locking extension 212 is locked to theplate 2, for example by rotating the locking drill guide 200 to engagethe threads 216 with a locking fastener aperture 40 a, the handle head116 is compressed between the plate 2 and the contact edge 218 to couplethe plate 2, the handle 100, and the locking drill guide 200 in apress-fit engagement. The assembly of the plate 2, handle 100, andlocking drill guide 200 can be manipulated using the handle 100 toinsert the plate 2 at least partially into a medullary canal of a bone.

In some embodiments, the channel 208 defines a predetermined interiorshape configured to couple to and/or interface with a driver insertedinto the channel 208. For example, in various embodiments, the channel208 can define an interior perimeter such as a hexagon or star shapeconfigured to interface with a driver to rotate the locking drill guide200 to couple the locking drill guide 200 to the plate 2.

In some embodiments, the outer surface of the locking drill guide 200includes one or more features configured to provide increased grip(e.g., friction) to a user when attaching and/or removing the lockingdrill guide 200 to the ISO plate 2 and/or the plate handle 100. Forexample, in various embodiments, the locking drill guide 200 can includegrooves, knurling, etching, and/or any other suitable surface treatment.In some embodiments, the locking drill guide 200 includes a torx-feature(or other coupling feature) for fixing the plate 16 to the insertionhandle 106 and/or separate the plate 16 from the insertion handle 106.

In some embodiments, the locking drill guide 200 (or a portion thereof)can be formed by injection molding material such as polycarbonate (PC),polyacrylamide, and/or any other suitable injection molding material.The injection molding can be formed over one or more structuralfeatures, such as ribs, lattice, etc. to provide increased strengthand/or to withstand forces applied during attachment and/or removal ofthe locking drill guide 200. In some embodiments, the locking drillguide 200 (or a portion thereof) is formed of a metal material formed byany suitable process, such as by stamping, bending, drilling, millingetc.

FIGS. 4A-4B illustrate a driver 300 including a driver handle 302 and adriver insert 304 configured to be engage and rotate at least oneelement of a plate inserter system, such as the locking drill guide 200described in conjunction with FIGS. 3A-3B. The driver handle 302includes a body 306 extending between a first end 308 and a second end310. The driver handle 302 defines a channel 312 extending from a distalface 314 of the driver handle into the body 306. The driver handle 302is similar to a screwdriver or other tool handle and is configured to begripped by a user.

The channel 312 is sized and configured to receive a portion of a driverinsert 304 therein. The driver insert 304 includes a body 320 extendingfrom a first end 322 to a second end 324 substantially along alongitudinal axis 326. The first (or proximal) end 322 of the driverinsert 304 is configured to be inserted into and retained within thechannel 312 defined by the driver handle 302. The driver insert 304 canbe permanently or releasably coupled to the driver handle 302. Forexample, in some embodiments, the driver handle 302 is overmolded ontothe driver insert 304 to permanently retain the driver insert 304 withinthe channel 312.

The second (or distal) end 324 of the driver insert 304 defines a driverhead 328. The driver head 328 has a complimentary shape with respect tothe interior perimeter of a channel 208 defined in the locking drillguide 200. The driver head 328 is configured to interface with andcouple to the fastener configured to be inserted through the ISO plate2, such as a locking fastener and/or a non-locking fastener. Forexample, in embodiments, the driver head 328 defines a complimentaryhexagon shape configured to fit within and interface with a hexagonalchannel formed in a first end of a locking and/or non-locking fastener.It will be appreciated that any suitable shape can be defined by thehead of the fastener and the driver head 328.

In some embodiments, the driver 300 (or a portion thereof) can be formedby injection molding material such as polycarbonate (PC),polyacrylamide, and/or any other suitable injection molding material.For example, in some embodiments, the driver handle 302 is formed of aninjection molding material by overmolding the driver handle 302 over adriver insert 304. The injection molding can be formed over one or morestructural features, such as ribs, lattice, etc. to provide increasedstrength and/or to withstand forces applied during insertion of one ormore fasteners using the driver 300. In some embodiments, the driver 300(or a portion thereof) is formed of a metal material formed by anysuitable process, such as by stamping, bending, drilling, milling etc.For example, in some embodiments, the driver insert 304 is formed of ametal material.

FIGS. 5A-5E illustrate a drill guide 400 configured to guide formationof a channel in a bone, in accordance with some embodiments. The drillguide 400 includes a handle portion 402 and a head portion 404. Thehandle portion 402 extends from a first end 406 a to a second end 406 bsubstantially along a central longitudinal axis 407 and is defined by anupper surface 408 a, a lower surface 408 b, and a perimeter wall 410.The handle portion 402 has a thickness extending between the uppersurface 408 a and the lower surface 408 b. In some embodiments, thehandle body 406 defines a plurality of gripping features 410 configuredto add friction and/or otherwise assist a user in gripping the handle402.

A head portion 404 is coupled to a distal end 406 b of the handleportion 402. The head portion 404 includes a neck 412 extending from thehandle portion 402 and an insert receiving portion 414. The neck 412 caninclude a first portion 416 a and a second portion 416 b coupled by anoffset portion 418. The offset portion 418 positions the second portion416 b within a plane that is vertically offset from a plane of the firstportion 416 a. In the illustrated embodiments, the first portion 416 aand the second portion 416 b are substantially parallel, although itwill be appreciated that the first portion 416 a and the second portion416 b can define an offset angle therebetween. The offset portion 418extends a predetermined distance to position the second portion 416 band the insert receiving portion 414 at a predetermined vertical offsetfrom the handle portion 402. In some embodiments, the neck 412 caninclude an offset angle with respect to the handle such that the insertreceiving portion 414 is positioned at a horizontal offset with respectto the handle portion 414.

The insert receiving portion 414 includes a body 420 defining an insertchannel 422 extending from a first end 424 a of the body to a second end424 b of the body. The insert channel 422 is configured to receive adrill guide insert therein. In the illustrated embodiment, the body 420defines a hollow cylinder, although it will be appreciated that the body420 can include any suitable shape defining an insert channel 422therethrough. Furthermore, the channel 422 can include any suitableshape complimentary to an outer surface of a drill guide insert 430, asdescribed in greater detail below. In the illustrated embodiment, theinsert channel 422 defines a central longitudinal axis 426 extendingsubstantially orthogonal to the central longitudinal axis 407 of thehandle portion 402, although it will be appreciated that the centrallongitudinal axis 426 of the insert channel 422 can be offset at apredetermined angle with respect to the central longitudinal axis 407 ofthe handle portion 402.

The drill guide insert 430 (as illustrated in FIG. 5D) includes asubstantially cylindrical body 432 extending from a first end 434 a to asecond end 434 b. In some embodiments, the body 432 has defines aninsertion portion 435 that has an outer diameter that tapers (orexpands) from a first diameter 435 a to a second diameter 435 b at asecond end 434 b. The cylindrical body 432 defines a guide channel 436extending from a first end 434 a to a second 434 b. In the illustratedembodiment, the guide channel 436 extends substantially along andparallel to a central longitudinal axis 438 of the cylindrical body 432,although it will be appreciated that the guide channel 436 can extendthrough the body 432 at an angle to and/or offset from the centrallongitudinal axis 438.

The guide channel 436 includes a circumference sized and configured toreceive a drill bit therethrough. The guide channel 436 is configured toguide the drill bit for drilling into a portion of a bone, such as ametatarsal. In some embodiments, the guide channel 436 defines acircumference substantially equal to a circumference of a drill bitconfigured to be inserted therein such that the drill bit is able torotate about a horizontal axis and move vertically but is prevented frommoving laterally and/or rotate about any other axis.

In some embodiments, the drill guide insert 430 includes a retainingportion 440 including one or more retention features 442 configured tomaintain the drill guide insert 430 within the channel 422 defined bythe insert receiving portion 414 of the drill guide 400. For example, inthe illustrated embodiment, the retention features 442 include aplurality of ribs having an increased diameter (or circumference) withrespect to the body 432 of the drill guide insert 430. The increaseddiameter of the ribs creates a friction fit against the inner surface ofthe channel 422 and maintains the drill guide insert 430 in a fixedposition with respect to the insert receiving portion 414. Althoughembodiments are illustrated with ribs, it will be appreciated that anysuitable retention feature, such as threads, ribs, pins, etc. can bealternatively and/or additionally included on the drill guide insert430.

As shown in FIG. 5A, the drill guide insert 430 is sized and configuredto be received within the insert channel 422 defined by the insertreceiving portion 414. As noted above, in some embodiments, the body 432of the drill guide insert 430 includes an outer diameter that tapersfrom a first diameter 435 a to a second diameter 435 b. The firstdiameter 435 a is less than an inner diameter of the insert channel 422such that the first end 434 a of the drill guide insert 430 can passinto and freely through the insert channel 422. In some embodiments, thesecond diameter 435 b is greater than the inner diameter of the insertchannel 422 such that a portion of the drill guide 430 positionedadjacent the second end 434 b is prevented from passing into and/orthrough the insert channel 422. In some embodiments, the taper of thebody 432 of the drill guide insert 430 is selected to provide a frictionfit with an inner surface of the guide channel 422, although it will beappreciated that the second end 434 b of the drill guide insert 430 caninclude a lip configured to abut the insert receiving portion 414without providing a friction fit within the guide channel 422.

In the illustrated embodiment, when the drill guide insert 430 ispositioned within the guide channel 422, the central longitudinal axis426 of the insert channel 422 and the central longitudinal axis 438 ofthe cylindrical body 432 are aligned. A user can manipulate the handleportion 402 to position a head portion 404 (and therefore the drillguide insert 430) in a desired position for formation of a hole within abone. For example, in some embodiments, the drill guide insert 430 issized and configured to be partially inserted into one of a lockingaperture 40 a, 40 b and/or a non-locking aperture 30 of the ISO plate 2.

FIGS. 6A-6C illustrate a broach 500 including a handle 502 and an insert504, in accordance with some embodiments. The handle 502 includes a body506 extending from a first end 508 a to a second end 508 b substantiallyalong a central longitudinal axis 510 and defined by a first surface 512a, a second surface 512 b, and a perimeter wall 514. The handle 502defines a first fastener aperture 516 a and a second fastener aperture516 b extending from the first surface 512 a to the second surface 512b. In some embodiments, the first and second fastener apertures 516 a,516 b are sized and configured to receive a fastener therein to couplethe handle 502 to an insert 504, as described in greater detail below.In some embodiments, the handle 502 defines a slot or channel 550extending from a first end 508 a into the body 506 sized and configuredto receive a portion of an insert 504 therein. In some embodiments, thechannel is sized and configured to receive a portion of an insert 504such that the first and second fastener apertures 516 a, 516 b arealigned with fastener apertures formed in the insert 504 (as describedin greater detail below) when the insert 504 is inserted into thechannel. In some embodiments, the insert 504 is overmolded by the firstend 508 a of the handle 502.

As illustrated in FIG. 6C, in some embodiments, an insert 504 includes abody 520 extending from a first end 522 a to a second end 522 bsubstantially along a central longitudinal axis 524 and defined by afirst surface 526, a second surface (not shown), and a perimeter wall528. The insert 504 includes a first portion 530 a configured to becoupled to a handle 502 and a second portion 530 b configured to be atleast partially inserted into a cut formed in a bone, such as ametatarsal. The body 520 defines a plurality of fastener apertures 532a-532 c extending from a first surface 526 to a second surface and sizedand configured to receive a fastener therein. In some embodiments, oneor more of the fastener apertures 532 a-532 c are positioned to alignwith fastener apertures 516 a, 516 b formed in the handle 502 when theinsert 504 is positioned adjacent to and/or inserted into the handle502.

As shown in FIG. 6A, the insert 504 is configured to be coupled to thehandle 502 to define a broach 500 configured to assist in formation ofan osteotomy in a bone, such as a metatarsal. As described in greaterdetail below, the second portion 530 b of the insert 504 is configuredto be inserted into a bone and leveraged to offset a first portion of abone with a second portion of the bone to form an osteotomy. In someembodiments, a leading edge 534 of the insert 504 is configured tofacilitate insertion into the bone. The leading edge 534 can besharpened to define a cutting edge and/or include a thickness less thanthe thickness of the insert 504.

In some embodiments, the broach handle 502 (or a portion thereof) can beformed by injection molding material such as polycarbonate (PC),polyacrylamide, and/or any other suitable injection molding material.The injection molding can be formed over one or more structuralfeatures, such as ribs, lattice, etc. to provide increased strengthand/or to withstand forces applied during insertion of the broach 500and formation of an osteotomy in a bone. In some embodiments, the insert504 (or a portion thereof) is formed of a metal material formed by anysuitable process, such as by stamping, bending, drilling, milling etc.

FIG. 7 illustrates a method 600 of forming an osteotomy in a bone andFIGS. 8A-8I illustrate various steps of the method 600 performed at asurgical site 700, in accordance with some embodiments. At step 602, acut 704 or osteotomy line is formed in a bone 702, such as a metatarsal.The cut 704 can be formed using any suitable instrument, such as amanual and/or electric cutting instrument such as a saw, burr, etc. Thecut 704 extends through the bone 702 to generate a first bone portion702 a and a second bone portion 702 b. For example, in some embodiments,the cut 704 is a distal transverse osteotomy formed through the firstmetatarsal at least 12 mm from an articular surface and just proximal toa capsular attachment, although it will be appreciated that the systemsand methods disclosed herein can be used with any suitable bone usingany appropriate surgical approach.

At step 604, and as illustrated in FIG. 8A, a broach 500 is partiallyinserted into the cut 704 between the first bone portion 702 a and thesecond bone portion 702 b. The broach 500 includes a handle 502 and aninsert 540 as discussed above. The leading edge 534 of the insert 504can be inserted into the cut 704 and a force applied to advance theinsert 504. The force may be applied by a surgeon by pushing on thehandle 402 and/or lightly striking the handle 502 with a strikinginstrument (e.g., hammer). At step 606, after inserting the broach 500,the broach is rotated (or leveraged) to displace the first bone portion702 a from the second bone portion 702 b, as shown in FIG. 8B. In someembodiments, the broach handle is maintained parallel with a medialborder of the foot during insertion. At optional step 608, a k-wire canbe used to provisionally fix the bone location after shifting.

At step 610, and as illustrated in FIG. 8C, an ISO plate, such as ISOplate 2 described above, is partially inserted into the second boneportion 702 b. For example, in some embodiments, the ISO plate 2 iscoupled to a plate handle 100 as illustrated in FIG. 2. The ISO plate 2is coupled to the plate handle 100 by a locking drill guide 200. Thelocking drill guide 200 includes a locking extension 212 that extendsthrough a portion of an opening 112 formed in the plate handle 100 andthat is coupled to a locking aperture 40 b formed in the ISO plate 2.The locking drill guide 200 locks the plate handle 100 and the ISO plate2 in a fixed engagement and transfers a force applied to the platehandle 100 to the ISO plate 2.

The plate handle 100 is used to apply a force to the ISO plate 2. Theleading edge 14 of the ISO plate 2 is sharpened to facilitate insertioninto the interior of the second bone portion 702 b. In some embodiments,a force is applied to the plate handle 100 by a striking instrument(e.g., hammer) to advance the ISO plate 2 into the second bone portion702 b. The ISO plate 2 is inserted to a predetermined depth within thesecond bone portion 702 b. For example, in some embodiments, the ISOplate 2 is inserted into a cavity formed by the broach 400 until aportion of the plate handle 100 (such as the head 116) contacts thesecond bone portion 702 b indicating the desired predetermined depth hasbeen reached.

At step 612, and as illustrated in FIG. 8D, a first fastener channel isformed in a first bone portion 702 a using a drill guide 400. The drillguide 400 includes a handle portion 402 and a drill guide insert 430positioned within a head portion 404 of the drill guide. The drill guideinsert 430 is configured to be at least partially inserted into thefirst locking aperture 40 a formed in the ISO plate 2. The drill guideinsert 430 defines a guide channel 432 sized and configured to receive adrill bit 720 therethrough. The drill bit 720 is inserted through theguide channel 432 and rotated to form a first fastener channel in thefirst bone portion 702 a.

At step 614, a first locking fastener 722 a is inserted through thefirst locking aperture 40 a and into the first fastener channel in thefirst bone portion 702 a to couple the ISO plate 2 to the first boneportion 702 a. The first locking fastener 722 a can be inserted usingany suitable driver, such as, for example, the driver 300 discussedabove. The driver 300 includes a driver insert 304 (or bit) configuredto be received within a slot defined in the head of the first lockingfastener 722 a to drive the first locking fastener into the firstfastener channel in the first bone portion 702 a and to drive the headof the first locking fastener 722 a into a locked engagement with thefirst locking aperture 40 a defined in the ISO plate 2, as shown in FIG.8E.

At step 616, and as illustrated in FIG. 8F, a second fastener channel isformed in the first bone portion 702 a, in accordance with someembodiments. The drill bit 720 is inserted through the guide channel 208defined in the locking drill guide 200 and rotated to form the secondfastener channel in the first bone portion 702 a. At step 618, thelocking drill guide 200 is separated from the ISO plate 2 and the platehandle 100. The locking drill guide 200 and the plate handle 100 can bediscarded after removal.

At step 620, and as illustrated in FIG. 8G, a second locking fastener isinserted through the second locking aperture 40 b and into the secondfastener channel in the first bone portion 702 a. The second lockingfastener 722 b can be inserted using any suitable driver, such as, forexample, the driver 300 discussed above. The driver 300 insert 304 isconfigured to be received within a slot defined in the head of thesecond locking fastener 722 b to drive the second locking fastener intothe second fastener channel in the first bone portion 702 a and to drivethe head of the second locking fastener 722 b into a locked engagementwith the second locking aperture 40 b defined in the ISO plate 2.

At step 622, and as illustrated in FIG. 8H, a fastener channel is formedin the second bone portion using the drill guide 400. The drill guideinsert 430 is configured to be at least partially inserted into thenon-locking aperture 30 formed in the ISO plate 2. The drill guideinsert 430 defines a guide channel 432 sized and configured to receive adrill bit 720 therethrough. The drill bit 720 is inserted through theguide channel 432 and rotated to form a fastener channel in the secondbone portion 702 b.

At step 624, and as illustrated in FIG. 8I, a non-locking fastener 724is inserted through the non-locking fastener aperture 30 in the ISOplate 2 and into the fastener channel formed in the second bone portion702 b. The non-locking fastener 724 is advanced to fix the position ofthe second bone portion 702 b with respect to the first bone portion 702a. In some embodiments, the non-locking fastener 724 is a compressionfastener configured to compress the second bone portion 702 b relativeto the first bone portion 702 a.

FIGS. 9A-9C illustrate a plate handle 100 coupled to an ISO plate 2 by afirst locking drill guide 200 a and a second locking drill guide 200 b,in accordance with some embodiments. The locking drill guides 200 a, 200b are similar to the locking drill guide 200 described above, andsimilar description is not repeated herein. The use of two locking drillguides 200 a, 200 b allows each of the fastener channels to be formed inthe second bone portion without using a drill guide 400. For example, invarious embodiments, a first fastener hole can be formed by inserting adrill through the first locking drill guide 200 a and a second fastenerhole can be formed by inserting the drill through a second locking drillguide 200 b. The first and/or second locking drill guides 200 a can beremoved and fasteners can be inserted through the ISO plate 2 and intothe second bone portion. The removal of each of the locking drill guides200 a, 200 b and insertion of a respective fastener can be performedsequentially and/or simultaneously.

FIG. 10 illustrates a locking drill guide 200 c having a channel 208 adefining at least a partial torx cross-section configured to receive atorx driver therein, in accordance with some embodiments. The lockingdrill guide 200 c is similar to the locking drill guide 200 discussedabove, and similar description is not repeated herein. In theillustrated embodiment, an opening 220 is defined at the first end 206of the locking drill guide 200 c. The opening 220 defines a first end ofthe channel 208 a and further defines a torx cross-section configured tointerface with a torx-driver (not shown) inserted at least partiallyinto the channel 208 a. In some embodiments, the entire channel 208 adefines a torx cross-section, although it will be appreciated that onlythe opening 220 and/or a portion of the channel 208 a can define thetorx cross-section. Although specific embodiments are discussed herein,it will be appreciated that the opening 220 and/or the channel 208 a canhave any suitable cross-sectional shape.

Although the subject matter has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodiments,which may be made by those skilled in the art.

What is claimed is:
 1. A system, comprising: an intraosseous slidingosteotomy (ISO) plate comprising a body extending between a first end, asecond end, a first surface, a second surface, and a perimeter wall,wherein the body defines at least one fastener aperture extending fromthe first surface to the second surface; a plate handle configured to becoupled to the ISO plate, the plate handle comprising a body including ahandle portion and a head portion, wherein the head portion comprises atleast one aperture; a locking element comprising a locking portion sizedand configured to extend through the at least one aperture defined inthe head portion of the plate handle to couple the plate handle to theISO plate; a non-locking drill guide having a body extending from afirst end to a second end substantially along a longitudinal axis, withan insert receiving portion coupled to a first end of the body by a necksuch that the neck positions the insert receiving portion at an offsetwith respect to the body; and a drill guide insert positioned at leastpartially within the insert receiving portion.
 2. The system of claim 1,wherein the locking element comprises a locking drill guide comprising abody extending from a first end to a second end and substantially alonga longitudinal axis, wherein the body defines a channel extending fromthe first end to the second end of the body.
 3. The system of claim 2,wherein the locking element comprises a locking feature configured tointerface with a feature defined in the at least one fastener apertureof the ISO plate to couple the locking element to the ISO plate.
 4. Thesystem of claim 3, wherein the locking feature comprises a first threadand the feature defined in the at least one fastener aperture comprisesa second thread complimentary to the first thread.
 5. The system ofclaim 1, wherein the drill guide insert comprises a tapered portionsized and configured to be inserted into the at least one fasteneraperture defined in the ISO plate.
 6. The system of claim 1, wherein theinsert receiving portion defines a channel having a central longitudinalaxis, and wherein the central longitudinal axis of the channel isorthogonal to the longitudinal axis of the body.
 7. The system of claim1, comprising a broach, wherein the broach comprises: a broach handleextending from a first end to a second end substantially along alongitudinal axis; and a broach insert configured to be coupled to thebroach handle, wherein the broach insert comprises an insertion portionhaving a first thickness and a coupling portion having a secondthickness, wherein the first thickness is less than the secondthickness.
 8. The system of claim 7, wherein the broach handle defines achannel sized and configured to receive a portion of the broach inserttherein.
 9. A kit, comprising: an intraosseous sliding osteotomy (ISO)plate comprising a body extending between a first end, a second end, afirst surface, a second surface, and a perimeter wall, wherein the bodydefines at least one fastener aperture extending from the first surfaceto the second surface; a plate handle; a locking element configured tocouple the ISO plate to the plate handle; a non-locking drill guidecomprising a body and an insert receiving portion coupled to the body;and a broach comprising a broach handle and a broach insert.
 10. The kitof claim 9, wherein the plate handle comprises a body including a handleportion and a head portion, wherein the head portion comprises at leastone aperture.
 11. The kit of claim 9, wherein the locking elementcomprises a locking drill guide comprising a body extending from a firstend to a second end and substantially along a longitudinal axis, whereinthe body defines a channel extending from the first end to the secondend of the body, and wherein the locking element comprises a lockingfeature configured to couple the locking element to the ISO plate. 12.The kit of claim 9, comprising a drill guide insert configured to bepositioned at least partially within the insert receiving portion of thenon-locking drill guide and wherein the drill guide insert comprises atapered portion sized and configured to be inserted into the at leastone fastener aperture defined in the ISO plate.
 13. The kit of claim 9,wherein the insert receiving portion is coupled to the first end of thebody by a neck, and wherein the neck positions the insert receivingportion at an offset with respect to the body, and wherein the insertreceiving portion defines a channel having a central longitudinal axis,and wherein the central longitudinal axis of the channel is orthogonalto a longitudinal axis of the body of the non-locking drill guide. 14.The kit of claim 9, wherein the broach insert comprises an insertionportion having a first thickness and a coupling portion having a secondthickness, wherein the first thickness is less than the secondthickness, and wherein the broach handle defines a channel sized andconfigured to receive a portion of the broach insert therein.
 15. Thekit of claim 9, wherein at least one of the plate handle, the lockingelement, the non-locking drill guide, or the broach comprises aninjection molded material.
 16. A method of forming an osteotomy,comprising: inserting a portion of a broach into a cut formed in a bone;rotating the broach to displace a first portion of the bone from asecond portion of the bone; inserting an intraosseous sliding osteotomy(ISO) plate into the second portion of the bone, wherein the ISO plateis coupled to a plate handle by a locking drill guide, and wherein theplate handle applies a force to the ISO plate; forming a first channelin the first portion of the bone using a non-locking drill guideinserted at least partially into a first aperture defined in the ISOplate; and inserting a first fastener through the first aperture definedin the ISO plate into the first channel in the first portion of the boneto couple the ISO plate to the first portion of the bone.
 17. The methodof claim 16, comprising: inserting a drill bit through a channel definedby the locking drill guide to form a second channel in the first portionof the bone; removing the locking drill guide from the ISO plate and theplate handle, wherein the plate handle is released from the ISO platewhen the locking drill guide is removed; and inserting a second fastenerthrough a second aperture defined in the ISO plate into the secondchannel in the first portion of the bone.
 18. The method of claim 17,comprising: positioning the non-locking drill guide at least partiallywithin a non-locking aperture defined through the ISO plate; forming achannel in the second portion of the bone by inserting a drill bitthrough the non-locking drill guide and into the second portion of thebone; and inserting a non-locking fastener through the second apertureand into the channel in the second portion of the bone to couple the ISOplate to the second portion of the bone.